Module 16 2024

23/10/2024

Penalties for Breach of MDR/IVDR Requirements

Enforcement is a national competency

Member States required to put in place “ effective, proportionate and dissuasive penalties ” (Article 113 MDR)

Focus will be in Member State where manufacturer or authorized representative is established

Both corporate and individual liability is possible ● Personal liability will focus on PRRC

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National Laws (France)

L. 5212-2 Code de la Santé Publique (CSP)

● Requires compliance with obligations under the MDR/IVDR by manufacturers,

authorized representatives, importers, distributors

● Imposes additional reporting obligations on HCPs and professional users

● “ Correspondant de matériovigilance ” for manufacturers or authorized

representative in France (Article R. 5212-13 CSP)

The Organisation for Professionals in Regulatory Affairs

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